Epitalon Not available

Longevity

Epitalon

An unapproved four-amino-acid peptide

Not FDA-approved · not available for sale or prescription

FDA advisory vote, July 2026 · FDA staff opposed · no FDA action

Stylised model of the real sequence

Overview.

Epitalon is not FDA-approved, and most of its evidence is from cell lines and rodents. It is a synthetic tetrapeptide developed by Russian gerontologists (Khavinson and colleagues) as an analogue of a pineal-gland peptide preparation, and it is often marketed with telomere and longevity claims. Human data are limited to a few small studies, including a 20-day randomized placebo-controlled study of a sublingual spray in 40 women with low melatonin output that measured melatonin and clock-gene markers, not telomeres or lifespan.

Also known as Epithalon · Epithalone · Ala-Glu-Asp-Gly · AEDG peptide

The molecule, decoded.

Sequence

AEDG

Length
4 residues
Molecular weight
390.4 g/mol
Formula
C14H22N4O9
CAS number
307297-39-8
Half-life
Not established
Routes studied
in vitro (cell culture), sublingual spray (one small 20-day randomized placebo-controlled human study), parabulbar injection (human, retinitis pigmentosa study, Khavinson et al. 2002), subcutaneous/intramuscular injection (reported by the peptide's Russian developer group)
Modifications
none reported (free linear tetrapeptide)

How it works.

Epitalon is reported to upregulate telomerase (hTERT) expression and, in cancer cell lines, to promote the alternative lengthening of telomeres (ALT) pathway, extending telomere length in vitro. It is also proposed to have antioxidant effects and to modulate pineal/circadian signaling (e.g., melatonin regulation), the basis for its 'anti-aging' and sleep-related marketing claims.

Evidence · Early or small human studies

What the research shows

animal and cell study2026

In a lymphoma drug-resistance model, targeting an LCP2-mediated senescence axis with Epitalon (combined with chaetocin) partially eliminated therapy-induced senescent NK/T-cell lymphoma cells and enhanced chemotherapy response in vivo, illustrating a senolytic rather than pro-longevity application distinct from Epitalon's typical anti-aging marketing.

in vivo ageing/senescence microenvironment model plus NK/T-cell lymphoma cell lines

cell study2025

In cultured human breast-derived cancer cell lines (21NT, BT474) and normal epithelial/fibroblast cells, Epitalon produced dose-dependent telomere-length extension in normal cells via hTERT mRNA upregulation and telomerase activity, while in cancer cells telomere extension additionally involved activation of the ALT (Alternative Lengthening of Telomeres) pathway; a minor ALT increase was also seen in normal cells. (A correction to this paper was published in November 2025.)

human breast cancer cell lines and normal human epithelial/fibroblast cell lines

cell study2025

In a high-glucose-injured human retinal pigment epithelial cell line (ARPE-19) modeling diabetic retinopathy, Epitalon restored delayed wound healing by inhibiting hyperglycemia-induced epithelial-mesenchymal transition and fibrosis-related gene upregulation.

ARPE-19 human retinal pigment epithelial cell line

What to know first.

Based on: lab and animal studies only; human safety is not established.

Reported side effects

  • Unknown: FDA found no clinical studies assessing epitalon's safety

Cautions

  • Human efficacy claims (telomere lengthening, longevity) are extrapolated from cell-line and animal data; the few human studies are small and short (e.g., 20 days) and measured melatonin or gene-expression markers, and FDA found no clinical studies assessing epitalon's safety

Checked 2026-09

Where it stands.

Not FDA-approved · not available for sale or prescription. Epitalon is not FDA-approved and is not available for sale or prescription. In July 2026, FDA staff recommended against adding it to the list of substances pharmacies may compound; FDA’s advisory committee voted 7–4, with 1 abstention, to recommend it anyway. The vote is advisory, and FDA has not acted on it.
FDA
Not approved. Epitalon held a US orphan-drug designation for retinitis pigmentosa from 2 Sep 2010 until it was withdrawn/revoked on 6 Jan 2016 (FDA briefing, citing FDA's orphan database). Reviewed at the PCAC on 24 Jul 2026 for insomnia: FDA proposed NOT adding epitalon (free base) or epitalon acetate; the committee voted 7 yes, 4 no, 1 abstain on each form to recommend inclusion (non-binding). No proposed or final FDA rule as of 26 Sep 2026.
Compounding
Nominated for the 503A Bulks List by LDT Health Solutions for the International Peptide Society (received 16 Nov 2018, FDA-2018-N-2973-0002) and by Wells Pharmacy Network (received 17 Dec 2020, FDA-2015-N-3534-0286). Held in 503A Category 2; both nominators withdrew on 14 Apr 2026, and epitalon now appears under 'nominated but withdrawn' on FDA's Category 2 page (updated 22 Apr 2026). FDA presented epitalon to the PCAC on 24 Jul 2026 and proposed NOT adding it; the committee voted 7-4-1 on each form to recommend inclusion (non-binding). As of 26 Sep 2026 FDA has published no proposed or final rule: the substance is not on the 503A bulks list (21 CFR 216.23, unchanged since 2019) and is not in 503A Category 1.
Sport (WADA)
Not named in the WADA 2026 Prohibited List. Because it has no known government approval for therapeutic use anywhere, it could plausibly be argued to fall under the general S0 'non-approved substance' catch-all in an anti-doping proceeding, although it is not explicitly named.
Enforcement
  • FDA warning letter to Tailor Made Compounding LLC, dated 2020-04-01, names Epitalon among bulk substances compounded without qualifying for a Section 503A exemption.
  • Tailor Made Compounding LLC pleaded guilty in October 2020 to distributing unapproved new drugs, including Epitalon; on 24 Feb 2021 it was sentenced to three years' probation and forfeited $1,788,906.82, and its owner received probation, home incarceration and a $20,000 fine (U.S. Attorney's Office, E.D. Kentucky).
References (7)
  1. PubMed · PMID 42209466
  2. PubMed · PMID 40908429
  3. PubMed · PMID 40493162
  4. U.S. FDA · download
  5. U.S. FDA · certain bulk drug substances use compounding may present signifi
  6. World Anti-Doping Agency
  7. U.S. FDA · tailor made compounding llc 594743 04012020

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